The RESET Clinical Trial: SPRINT® Peripheral Nerve Stimulation for the Treatment of Back Pain

Not Applicable

Active, not recruiting

• Conditions: Back Pain; Low Back Pain

• Registration Number: NCT04246281
• Lead Sponsor: SPR Therapeutics, Inc.

Brief Summary

The purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. Stimulation is delivering small amounts of electricity to the nerves in your low back. This study will use a device called the SPRINT Peripheral Nerve Stimulation (PNS) System. The device is cleared by the FDA for up to 60 days of use for the relief of chronic or acute pain (including back pain)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-19
• Study First Submitted QC: 2020-01-28
• Study First Posted: 2020-01-29
• Study Start: 2020-06-17
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2026-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Chronic low back pain

Key

Exclusion Criteria

• Body Mass Index (BMI) > 40
• Prior lumbar surgery
• Implanted electronic device
• Pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Study-Related Adverse Events (AEs)	24-months post-SOT	Occurrence and type of study-related AEs
Reduction in average pain intensity	Up to 3-months after Start of Therapy (SOT)	Average pain is measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Change	3-months after SOT	Measured using the Patient Global Impression of Change (PGIC) survey. The PGIC scale asks subjects to rate their improvement with treatment on a 7-point scale (centered at 4) that ranges from "very much worse" to "very much improved" relative to baseline.
Reduction in pain interference	Baseline, 3-months after SOT	Measured using question 9 from the Brief Pain Inventory- Short Form. This question asks the subject to rate the degree to which their pain has interfered with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life on a scale of 0 to 10, where 0 is "does not interfere" and 10 is "completely interferes" within the last week.
Reduction in disability	Baseline, 3-months after SOT	Measured using the Oswestry Disability Index (ODI). The ODI asks subjects to rate how their back pain impacts ten components of everyday life. For each section, the answers correlate to a scale which ranges from 0 to 5, where 0 is no disability and 5 is maximum disability.
Durability of reductions in pain intensity	Baseline, 6-months after SOT, 9-months after SOT, 12-months after SOT, 18-months after SOT, 24 months after SOT	Measured using question 5 from the Brief Pain Inventory- Short Form (BPI-5). BPI-5 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Reduction in worst pain intensity	Baseline, 3-months after SOT	Measured using question 3 from the Brief Pain Inventory- Short Form (BPI-3). BPI-3 is a scale of 0 to 10 where 0 represents no pain and 10 represents worst pain.
Change in health-related quality of life	Baseline, 3-months after SOT	Measured using the EQ-5D survey. The EQ-5D is a five-level scale. Each level is coded from 1 to 5, where 1 indicates no problems and 5 indicates extreme problems. The EQ-5D also includes a 0 to 100 scale for health status, where 0 indicates "the worst health you can imagine" and 100 indicates "the best health you can imagine".
Change in analgesic medication usage	Baseline, 3-months after SOT	Analgesic medication consumption will be collected.

Trial Locations

Locations (18)

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

IPM Medical Group; 🇺🇸 Walnut Creek, California, United States

Denver Back Pain Specialists; 🇺🇸 Greenwood Village, Colorado, United States

International Spine, Pain & Performance Center; 🇺🇸 Washington, District of Columbia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwest Speciality Hospital; 🇺🇸 Post Falls, Idaho, United States

Millennium Pain Center; 🇺🇸 Bloomington, Illinois, United States

Sinai Hospital of Baltimore; 🇺🇸 Baltimore, Maryland, United States

Premier Pain Centers; 🇺🇸 Shrewsbury, New Jersey, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

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